# K190677: EndoClot

- Pathway: 510(k) (Traditional)
- Applicant: Endoclot Plus Co., Ltd.
- Decided: Jan 29, 2021 after 686 days
- Product code: QAU (Hemostatic Device For Endoscopic Gastrointestinal Use)
- Device class: 2
- Regulation: 21 CFR 878.4456
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042834 (2005). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170015: Hemospray Endoscopic Hemostat, Wilson-Cook Medical, Inc. (2018) Summary page 4.
- K162197: EndoClot, Endoclot Plus Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K234131: Resolv Endoscopic Hemostat System (2024), 0 descendants of its own

## Indications for use
EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.

Source page: https://510kreport.com/device/K190677
Methodology: https://510kreport.com/methodology